Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-12-15 to 2016-02-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Name: Genamin DMG 100
Batch No.: RAK-SEL-00067
CAS No.: 76326-99-3
Molecular Weight: 209.24
Chemical Name: N,N-Dimethyl-D-glucamine // 1-Deoxy-1-(dimethylamino)-D-glucitol // D-Glucitol, 1-deoxy-1-(dimethylamino)-
Physical State at RT: solid
Colour: white
pH: no data
Purity: 99.1%
Date of Analysis: 28 August 2015
Storage Conditions: room temperature
Expiry Date: 28 August 2018
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Housing and Feeding Conditions:
- Semi barrier in an air-conditioned room
- Temperature: 18 +/- 3 °C (recommendations of TVT, GV-SOLAS)
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to irradiated hay briquettes and to Altromin 2123 maintenance diet for rabbits (lot no. 0614), rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich
- Housed in ABS-plastic or Noryl rabbit cages, floor 4200 cm2
- Adequate acclimatisation period (at least 5 days) under laboratory conditions

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
aqua ad injectabilia (AlleMan Pharma, lot no. 503424, expiry date: 28/02/2018)
Controls:
no
Amount / concentration applied:
Dose Level
A dose of 0.5 g of the test item was applied to each test site.
Duration of treatment / exposure:
Exposure Period
The test item was held in contact with the skin throughout a 4-hour period.
At the end of the exposure period, the residual test item was removed with physiological saline NaCl 0.9% (B. Braun Melsungen, lot no. 1406788,
expiry date: 31/05/2017).
Observation period:
Observation Period
The animals were observed for 72 hours after the patch removal.
Number of animals:
3
Details on study design:
Clinical Observation:
The animals were examined for signs of erythema and oedema 1 hour after the patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema 24, 48 and 72 hours after the patch removal. Dermal irritation was scored and
recorded according to the grades in the table below . Any other signs such as hyperplasia, scaling, discolouration, fissures and scabs or any
systemic effects were also recorded.
For the initial test in one animal, the test site was also examined immediately after the patch had been removed.

Evaluation of Results:
Individual reactions for each animal were recorded according to the grades in the table below at each time of observation.
Nature, severity and duration of clinical observations were described.
The body weight changes were summarised in a tabular form.
With few exceptions, data were captured using the validated departmental computerised system E WorkBook (version 9.4.0, ID Business Solutions Ltd.).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Neither irritant nor corrosive effects were observed on the intact skin of three male rabbits (strain NZW) after a contact time of 4 hours.
Other effects:
Neither mortalities nor significant clinical signs of toxicity were observed.
There were no significant body weight changes during the observation period.

Any other information on results incl. tables

Individual Data - Evaluation of Dermal Irritation

Animal No. Timepoint Irritation
Oedema Erythema Comment
Test Item Control Test Item Control Test Item Control
1 0h 0 0 0 0 - -
1h 0 0 0 0 - -
24h 0 0 0 0 - -
48h 0 0 0 0 - -
72h 0 0 0 0 - -
2 0h         - -
1h 0 0 0 0 - -
24h 0 0 0 0 - -
48h 0 0 0 0 - -
72h 0 0 0 0 - -
3 0h         - -
1h 0 0 0 0 - -
24h 0 0 0 0 - -
48h 0 0 0 0 - -
72h 0 0 0 0 - -

0-4 = grade

Clinical Signs

Animal No.  Timepoint Systemic Findings Local Findings Comment
Test Item Test Item Control Test Item Control
1 0h nsf nsf nsf - -
1h nsf nsf nsf - -
24h nsf nsf nsf - -
48h nsf nsf nsf - -
72h nsf nsf nsf - -
2 1h nsf nsf nsf - -
24h nsf nsf nsf - -
48h nsf nsf nsf - -
72h nsf nsf nsf - -
3 1h nsf nsf nsf - -
24h nsf nsf nsf - -
48h nsf nsf nsf - -
72h nsf nsf nsf - -

* = apart from erythema/oedema; nsf = no specific findings

Absolute Body Weights (kg)

Animal No. Bodyweight (kg)
Start of Study 72 Hours Post Application
1 3.6 3.6
2 4 4
3 4.5 4.6

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritation property of the registration substance was investigated according to the Guideline OECD 404. The registration substance did not induce any effect in this study. No classification is justified.
Executive summary:

The skin irritation property or the registration substance was investigated according to the Gudieline OECD 404. Rabbits were dermally treated with 0.5g of the registration substance semi-occusively for 4 hours. No effect was found.

No classification is justified.